Translatability Of T Cell TransAct™ For T Cell Activation Process Development

Process development is riddled with challenges — and one major obstacle involves finding reagents that can achieve an equivalent physiological response when moving from a research setting to commercial manufacturing. A critical aspect is the ability to take a protocol developed to activate T cells, such as one optimized in the laboratory, and then translate it into a process intended for commercial manufacturing for clinical applications.

Herein, we provide protocol guidance that demonstrates how to best attain equivalent results when using two different T Cell TransAct formats. This study illustrates the equivalent physiological response of T cell subsets to the activation-reagent T Cell TransAct. To demonstrate this equivalent physiological response, both formats of the reagent —research-use T Cell TransAct and MACS^® GMP T Cell TransAct™ — were used.

We employed two parallel sets of experiments using a non-automated method that reflects a laboratory setting, while making pertinent observations of activation and exhaustion markers based on flow cytometry data throughout 10 days of cultivation.